Tag: Food and Drug Administration

Comirnaty

Yes, the FDA really HAS given full approval to the Pfizer/BioNTech COVID-19 vaccine

After the FDA announcement a week ago that Comirnaty, the COVID-19 mRNA vaccine developed by BioNTech and Pfizer, had been approved, it took less than a day for antivaxxers to spin a conspiracy theory claiming that the FDA hadn't really approved the Pfizer vaccine at all and that Comirnaty wasn't available, all to protect Pfizer from liability. It's a superficially plausible conspiracy...

/ August 30, 2021

Court overturns FDA ban on electric shock device used on special needs students

An FDA ban on using electric shock devices to control behavior in special needs students, a method deemed "torture" in a U.N. report, was overturned in a flawed court decision. The FDA should appeal.

/ July 15, 2021
Central Dogma of Molecular Biology

The latest antivax false claim: mRNA vaccines against COVID-19 are not vaccines but “medical devices” or “gene therapy”

There's a new antivaccine talking point in town, and it's just as much disinformation as other antivaccine talking points. It's the claim that mRNA COVID-19 vaccines are not really vaccines but "medical devices," "gene therapy," or "experimental biologics" and that they were falsely classified as vaccines in order to bypass safety testing. Here, we discuss why this claim is utter nonsense based...

/ February 8, 2021

FDA and FTC issue more warning letters citing products and services making illegal COVID claims

The FDA and FTC have issued hundreds of warnings to companies selling products and services claiming, without adequate evidence, that they can prevent or treat COVID-19, but the possibility of government action doesn't seem to be a deterrence.

/ November 19, 2020

Joe Biden defeated Donald Trump. Now what for science-based medicine?

In 2016 and 2020, scientists expressed surprise and alarm at the results of the Presidential election. In 2016 it was alarm that someone as antiscience as Donald Trump was elected, and in 2020 it was over how close the election was, given Trump's dismal record on science, medicine, and the COVID-19 pandemic. Are scientists out of touch? And now what, for federal...

/ November 9, 2020
HHS

Vaccine safety monitoring in the age of the COVID-19 pandemic

Last year, the Trump administration essentially disbanded the National Vaccine Program Office, folding it into an office focused on infectious diseases. Then the COVID-19 pandemic hit. What does this mean for monitoring the safety of the soon-to-be-approved COVID-19 vaccines?

/ October 26, 2020

Government watchdog to investigate politicization of CDC and FDA during COVID-19 pandemic

Based on numerous reports of White House interference, a government watchdog will investigate politicization of the CDC's and FDA's actions during the coronavirus pandemic.

/ October 22, 2020
COVID-19 vs. FDA and CDC

In the age of the COVID-19 pandemic, can we trust the CDC and FDA any more?

Since the COVID-19 pandemic reached the US, increasing concern has been expressed about the politicization of the CDC and FDA due to pressure from the Trump administration to downplay the severity of the pandemic and push out treatments and a vaccine as fast as possible, potentially at the expense of safety. This has led me to a disturbing question: Can I trust...

/ September 14, 2020

FDA warns companies selling illegal hangover remedies

The FDA recently warned seven companies not to claim that their dietary supplements can prevent, treat, or cure a hangover, because only FDA-approved drugs can make such claims. The agency also warned that NAC, a popular supplement ingredient, cannot legally be used in dietary supplements.

/ September 10, 2020

FDA Decision on Oleandra

FDA rejects the application for oleandrin as a new dietary ingredient, but flaws in the regulations remain.

/ September 9, 2020